Chromatography Forum

Dear All,

Is there any guideline available for the time window for the analysis of the stability samples?

i.e. in how much time the sample can be analysed after withdrawl form the stability chambers?

Please share your expertise.

Thanks / Reards

Once we pull a sample from a chamber, it sits at controleld room temperature until analyzed. I don't think there's any cutoff as to how long it can sit, but sooner is better as you will do yourself no favors by letting them sit for weeks before testing them. Stability of prepared sample solutions is usually addressesd as a part of the method validation work. We prepare replicate preps of a sample and inject them after various amounts of time. If the RSD among such replicates is adequately small, we allow prepared samples to be injected up to (however many) hours after being prepared (we typically run these out as long as 72 hours).

Hi,

At the Pharma company where I worked previously, our rule was that the length of time until assay had to be less than 20% of the storage time. For example if our sample was pulled for the 1 month time point (30 days) we had 6 days to perform the assay. I don't know if that was just an internal practice or a regulatory rule. The ICH web page has several documents about stability studies. Their link is http://www.ich.org/cache/compo/276-254-1.html
You might be able to find the answer to your question in one of their documents.

KarenJ